Metacognitive Therapy for Patients With Obsessive-Compulsive Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Philipps University Marburg Medical Center
Sponsor:
Collaborator:
Psychotherapie-Ambulanz Marburg e.V.
Information provided by (Responsible Party):
Julia Anna Glombiewski, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT01483339
First received: November 16, 2011
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

Cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder. However, the majority of treated patients remain symptomatic. The metacognitive therapy by Wells (1997) could achieve substantial gains in first pilot studies. The purpose of this study is to investigate this approach with a randomized controlled trial by comparing metacognitive therapy with exposure and response prevention for obsessive-compulsive disorder.


Condition Intervention Phase
Obsessive-Compulsive Disorder
Behavioral: Metacognitive Therapy
Behavioral: Exposure and Response Prevention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metacognitive Therapy Versus Exposition With Response Prevention for Patients With Obsessive-Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Change in Symptom Severity (Yale Brown Obsessive-Compulsive Scale; YBOCS) from Pretest to Posttest to Follow-up [ Time Frame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Symptom Severity (Padua Inventory; PI) from Pretest to two in-between timepoints to Posttest to Follow-up [ Time Frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ] [ Designated as safety issue: No ]
  • Change in Metacognitions from Pretest to two in-between timepoints to Posttest to Follow-up [ Time Frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ] [ Designated as safety issue: No ]
    Metacognitions (MCQ), Thought Fusion Inventory (TFI), Thought Action Fusion Scale (TAF-scale), Beliefs About Rituals Inventory (BARI), Stop Signals Questionnaire (SSQ), Detached Mindfulness Questionnaire (DMQ)

  • Change in Obsessive Beliefs (Obsessive-Beliefs Questionnaire, OBQ) from Pretest to two in-between timepoints to Posttest to Follow-up [ Time Frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ] [ Designated as safety issue: No ]
  • Change in Behavioral Avoidance (Behavioral Avoidance Test, BAT) from Pretest to two in-between timepoints to Posttest to Follow-up [ Time Frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ] [ Designated as safety issue: No ]
  • Change in Depression (Beck Depression Inventory, BDI) from Pretest to Posttest to Follow-up [ Time Frame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ] [ Designated as safety issue: No ]
  • Change in Anxiety (Beck Anxiety Inventory, BAI) from Pretest to Posttest to Follow-up [ Time Frame: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ] [ Designated as safety issue: No ]
  • Change in Patient-Therapist-Alliance from Pretest to two in-between timepoints to Posttest to Follow-up [ Time Frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ] [ Designated as safety issue: No ]
    Self rating and clinician rating of Helping Alliance Questionaire (HAQ) and Working Alliance Inventory (WAI)

  • Change in Symptom Severity (Clinical Global Impressions; CGI) from Pretest to two in-between timepoints to Posttest to Follow-up [ Time Frame: from Pretest (admission) to two in-between timepoints (an expected average of 5 and 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission) ] [ Designated as safety issue: No ]
  • Treatment expectancy (Treatment Expectancy Questionnaire) after the first treatment session [ Time Frame: after the first treatment session (an expected average of 1 week after admission) ] [ Designated as safety issue: No ]
  • Satisfaction with the treatment at Posttest [ Time Frame: immediately after completion of therapy (an expected average of 3 months after admission) ] [ Designated as safety issue: No ]
  • Change in Symptom Severity (Obsessive-Compulsive Disorder Scale; OCD-S) measured before every treatment session [ Time Frame: from the first treatment session (an expected average of 1 week after admission) to the last treatment session (an expected average of 3 months after admission) on a weekly basis ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metacognitive Therapy Behavioral: Metacognitive Therapy
Metacognitive Therapy for OCD according to Wells (1997)
Experimental: Exposure and Response Prevention Behavioral: Exposure and Response Prevention
Exposure and Response Prevention for OCD according to Kozak & Foa (1997)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis: obsessive-compulsive disorder
  • German-speaking
  • Agreeing to participate, verified by completion of informed consent

Exclusion Criteria:

  • Current or past diagnosis of substance dependence, psychosis, neurological conditions
  • Mental retardation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483339

Contacts
Contact: Cornelia Exner, Prof. Dr. +49 341- 97 35 930 exnerc@uni-leipzig.de

Locations
Germany
Philipps Univerity Marburg, Department of Clinical Psychology and Psychotherapy Recruiting
Marburg, Hessen, Germany, 35037
Contact: Cornelia Exner, Prof. Dr.    +49 341 / 97-35931    exnerc@uni-leipzig.de   
Contact: Anke Haberkamp, Dipl.-Psych.    +49 6421/28-23656    anke.haberkamp@staff.uni-marburg.de   
Principal Investigator: Julia A. Glombiewski, Dr.         
Sub-Investigator: Jana Hansmeier, Dipl.-Psych.         
Sponsors and Collaborators
Philipps University Marburg Medical Center
Psychotherapie-Ambulanz Marburg e.V.
Investigators
Principal Investigator: Cornelia Exner, Prof. Dr. University of Leipzig
Study Director: Winfried Rief, Prof. Dr. Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
  More Information

Additional Information:
No publications provided

Responsible Party: Julia Anna Glombiewski, Principal Investigator, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01483339     History of Changes
Other Study ID Numbers: MCT_OCD_2011
Study First Received: November 16, 2011
Last Updated: April 24, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on August 20, 2014